Ex Parte Vaughn et al

Patent Trial and Appeal Board

Sep 28, 2018

13507261 (P.T.A.B. Sep. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/507,261
13565 7590
Dentons US LLP
4655 Executive Drive
Suite 700
San Diego, CA 92121
06/15/2012
09/28/2018
FIRST NAMED INVENTOR
Daniel Edward Vaughn
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
33320.03097.USOJ/ 3097 9571
EXAMINER
EPSTEIN, TODD MATTHEW
ART UNIT PAPER NUMBER
1652
MAIL DATE DELIVERY MODE
09/28/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL EDWARD VAUGHN,
DOUGLAS BOYER MUCHMORE, and
GREGORY I. FROST 1
Appeal2017-002692
Application 13/507 ,261
Technology Center 1600
Before RICHARD J. SMITH, TA WEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of controlling blood glucose in a subject, which have been rejected
as anticipated and/or obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE and enter a new ground of rejection under 37 C.F.R.
§ 41.50(b).
1 Appellants identify the Real Party in Interest as Halozyme, Inc. (Appeal
Br. 2.)
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STATEMENT OF THE CASE
Patients with diabetes and critically ill patients may experience
hyperglycemia, i.e., an excess of glucose in the blood stream. (Spec. 2: 15-
18.) Fast-acting insulins have been administered as a therapeutic to control
blood glucose level. (Id. at 2: 18-24.) According to the Specification,
however, current fast-acting insulins have a delay in absorption and action,
which results in the need to administer the insulin preparation in advance of
meals, as well as dosages that lead to an extended duration of action that
contributes to hypoglycemia and possibly obesity. (Id. at 2:24--33.) The
Specification teaches that "co-formulating or co-mixing fast acting insulin
... with a hyaluronan-degrading enzyme[], such as PH20, acts to accelerate
absorption and action compared to insulin alone when administered by
subcutaneous infusion or pump infusion, and thereby result[ s] in
improvements in glycemic control." (Id. at 44:5-10.)
The Specification further teaches that
[p ]revious studies ... have demonstrated inconsistency in
both exposure to and action of rapid acting analog insulin
as insulin infusion set ages. While a faster-in/faster-out
absorption exists late in infusion set life, the insulin
absorption is not consistent because early in infusion set
life the insulin absorption that is observed is much less
than occurs later in infusion set life. This results i[ n] a
variability in insulin exposure upon [ continuous
subcutaneous insulin infusion (CSII)] therapy, since
insulin absorption only increases or accelerates later in
infusion set life.
(Id. at 44:16-24 (citations omitted).) The Specification teaches a method in
which "the hyaluronan-degrading enzyme is administered at the initiation of
infusion set [ using] a leading edge dosage regime prior to infusion with an
insulin in a CSII therapy," whereby "the hyaluronan-degrading enzyme (e.g.
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PH20) can reduce the acceleration of insulin exposure and/or action over
infusion set life and provide a more consistent delivery of a super-fast acting
insulin that mimic the endogenous post-prandial insulin release of a
nondiabetic subject." (Id. at 45:16-30.)
Claims 1-14, 16, 19-21, 25-29, 32, and 33 are on appeal. Claim 1 is
illustrative and reproduced below:
1. A method of controlling blood glucose in a subject by
continuous subcutaneous insulin infusion (CSII) therapy, comprising:
a) first administering a composition comprising a soluble PH20
polypeptide to the subject, wherein:
the soluble PH20 polypeptide is injected into the subject as a
bolus; and
the soluble PH20 polypeptide is active at neutral pH; and then
b) continuously infusing a composition comprising a fast-acting
insulin by CSII therapy with a continuous infusion device, wherein:
the CSII therapy comprises continuous infusion of the fast-
acting insulin for more than one day to the subject and
following the injection of the hyaluronidase; and
the soluble PH20 polypeptide in step a) is administered
separately from the insulin and only one time before
commencing the continuous CSII of the fast-acting insulin for
more than a day, whereby the difference in insulin absorption is
reduced over the course of the insulin infusion compared to
CSII performed in the absence of administering the soluble
PH20 polypeptide prior to infusing the fast-acting insulin
composition.
(Appeal Br. 54 (Claims App.) (formatting added).)
The Examiner rejects claims 1-5, 9-11, 13-14, 16, 19-21, 25-29, 32,
and 33 under pre-AIA 35 U.S.C. § I02(b) as being anticipated by Frost. 2
(Ans. 2.)
2 Frost et al., US 2009/0304665 Al, published Dec. 10, 2009.
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The Examiner rejects claims 1-14, 16, 19-21, 25-29, 32, and 33
under pre-AIA 35 U.S.C. § 103(a) as obvious over Frost. (Ans. 7.)
I.
Issue
The Examiner has rejected claims 1-5, 9-11, 13-14, 16, 19-21, 2 5-
29, 32, and 33 as being anticipated by Frost. The Examiner finds that Frost
teaches each element of these claims. (Ans. 2---6.) Appellants contend,
among other things, that the Examiner's anticipation rejection is improper
because it is based on picking and choosing from among a multitude of
alternatives. (Appeal Br. 13.)
The issue with respect to this rejection is whether a preponderance of
the evidence of record supports the Examiner's finding that Frost discloses
all of the limitations of claims 1-5, 9-11, 13-14, 16, 19-21, 25-29, 32, and
33, with those limitations arranged or combined in the same way as recited
in the claims.
Analysis
On balance, we find Appellants to have the better argument. In
particular, the Examiner cites paragraphs 3 83 and 3 84 of Frost as disclosing
all of the limitations of claim 1 other than PH20 as the hyaluronan degrading
enzyme, use of a continuous infusion device for delivery of the insulin
composition, and subcutaneous delivery of insulin. (Ans. 26.)
Paragraphs 383 and 384 of Frost state:
The hyaluronan degrading enzyme can be
administered prior, subsequently, intermittently or
simultaneously to the insulin preparation. Generally, the
hyaluronan degrading enzyme is administered prior to or
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simultaneously with administration of the insulin
preparation to permit the hyaluronan degrading enzyme to
degrade the hyaluronic acid in the interstitial space. In one
example, the insulin composition and hyaluronan
degrading enzyme composition are co-formulated and,
therefore, administered simultaneously. In another
example, the hyaluronan degrading enzyme composition
is administered prior to the insulin composition, such as
1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes or
more prior to administration of the insulin preparation.
In some examples, the hyaluronidase is administered
together with the insulin preparation. As will be
appreciated by those of skill in the art, the desired
proximity of co-administration can be readily optimized
by testing the effects of administering the agents at varying
times in suitable models, such as in suitable animal
models.
Both the insulin preparation and the hyaluronan
degrading enzyme preparation can be administered at
once, or can be divided into a number of smaller doses to
be administered at intervals of time. Selected insulin
preparations can be administered in one or more doses
over the course of a treatment time for example over
several minutes, hours, days, weeks, or months. In some
cases, continuous administration is useful. It is
understood that the precise dosage and course of
administration depends on the indication and patient's
tolerability.
(Frost ,r,r 383-384 (emphases added).)
The Examiner finds Frost's paragraphs 383 and 384 to be "clearly a
single connected disclosure" and analogizes the disclosure in Frost to a
"generic disclosure" that anticipates everything within the genus. (Ans. 27.)
In particular, the Examiner finds that, while Frost teaches "several possible
configurations" of timing, mechanism, and duration of administration, a
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skilled artisan can "easily envision" the claimed invention based on Frost's
disclosure. (Ans. 27-28.)
We are not persuaded and find that, while Frost separately discloses
administering hyaluronan degrading enzyme prior to insulin, administering
insulin for a period of more than one day, and administering insulin
continuously, arriving at the claimed invention based on these disclosures is
more akin to "picking, choosing, and combining various disclosures not
directly related to each other by the teachings of [Frost]." In re Arkley, 455
F.2d 586, 587 (CCPA 1972) (emphasis added). While "[s]uch picking and
choosing may be entirely proper in the making of a 103, obviousness
rejection, ... it has no place in the making of a 102, anticipation rejection."
Id.
Accordingly, we reverse the Examiner's rejection of claim 1 as
anticipated by Frost. We also reverse the rejection of claims 2-5, 9-11, 13,
14, 16, 19-21, 25-29, 32, and 33, which all depend directly or indirectly
from claim 1, for the same reasons.
II.
The Examiner has rejected claims 1-14, 16, 19-21, 25-29, 32, and 33
as obvious over Frost. The Examiner states, however, that claims 1-5, 9-11,
13, 14, 16, 19-21, 25-29, 32, and 33 are rejected as obvious solely because
they are found to be anticipated by Frost. 3 (Ans. 46.) As discussed above,
3 The Examiner states that "claims 6-9 and 12 are the only claims addressed
in the Grounds for Rejection as being obvious over Frost et al. for reasons
other than anticipation." (Ans. 46.) However, claim 9 is also included in the
anticipation rejection, and the Examiner provides no separate obviousness
analysis for claim 9. Thus, we understand the Examiner's obviousness
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we reverse the Examiner's rejection of claims 1-5, 9-11, 13, 14, 16, 19-21,
25-29, 32, and 33 as anticipated by Frost. Accordingly, we also reverse the
Examiner's rejection of claims 1-5, 9-11, 13, 14, 16, 19-21, 25-29, 32, and
33 as obvious over Frost. Furthermore, because claims 6-8 and 12 depend
from claim 1, and because the Examiner provided no reason for combining
the various disclosures in Frost to arrive at the invention of claim 1, we
reverse the rejection of claims 6-8 and 12 as obvious over Frost for the same
reasons. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent
claims are nonobvious if the independent claims from which they depend are
nonobvious.").
III.
Under the provisions of 37 C.F .R. § 41.50(b ), we enter the following
new ground of rejection: Claim 1 is rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious based on Frost.
Claim Construction
We begin with claim construction to determine the meaning of the
limitation, "the soluble PH20 polypeptide ... is administered ... only one
time before commencing the continuous CSII of the fast-acting insulin for
more than a day." In this regard, during prosecution we give claims their
broadest reasonable construction in light of the specification as it would be
interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997).
rejection of claim 9 over Frost is also based solely on the fact that the
Examiner finds claim 9 to be anticipated by Frost.
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As Appellants appear to acknowledge, while the limitation at issue
requires administration of the soluble PH20 polypeptide bolus only once
before commencing the continuous CSII, the claim language itself is at best
ambiguous as to whether additional polypeptide may be administered during
the course of CSII after its commencement. (Appeal Br. 5 ( offering to
amend claim 1 to clarify that the PH20 polypeptide is not administered
during the continuous CSII for more than a day, if the Examiner reopens
prosecution and indicating that the proposed amendment addresses the
Examiner's concems).)4
Neither does the Specification require Appellants' apparent narrower
construction of the phrase- i.e., that the PH20 polypeptide would not be
administered during the course of the CSII. (See, e.g., Appeal Br. 17 (stating
that in the instant methods "the hyaluronidase is not co-administered
throughout the infusion set life").) In describing the leading edge dosage
regimen of the invention, for instance, the Specification explains that, "over
the course of infusion set there is an accelerated action of insulin late in
infusion set life compared to early times of infusion," which "renders insulin
action and absorption variable and inconsistent" over the lifetime of the
infusion set. (Spec. 55:31-34.) The Specification goes on to say that, in the
methods of the invention, "the differences in insulin exposure and/or action
over time can be minimized by administering a hyaluronan-degrading
enzyme at or near the initiation of infusion set use, followed by CSII with
4 Although Appellants have offered to amend the claims, we consider the
claims as drafted in the appeal before us rather than claims as they may or
may not be amended. We further note that this opinion does not intend to
suggest that any particular claim would be non-obvious over Frost under
Appellants' proposed construction.
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insulin alone or an insulin-PH20 super-fast action composition." (Id. at
56: 1--4 ( emphasis added).)
Accordingly, we find that, in light of the Specification as it would be
interpreted by a skilled artisan, the broadest reasonable construction of the
phrase, "the soluble PH20 polypeptide ... is administered ... only one time
before commencing the continuous CSII of the fast-acting insulin for more
than a day," does not preclude administration of PH20 polypeptide during
the continuous CSII.
Obviousness over Frost
Findings of Fact
1. Frost teaches "super fast-acting insulin compositions containing
a therapeutically effective amount of a fast-acting insulin to control blood
glucose levels and an amount of a hyaluronan degrading enzyme sufficient
to render the composition a super fast-acting insulin composition." (Frost
2. Frost teaches that "[ e ]xemplary hyaluronan degrading enzymes
are hyaluronidases, particularly soluble hyaluronidases, such as PH20, or a
truncated form thereof." (Id. ,r 20.)
3. Frost teaches that PH20 is an example of a neutrally active
hyaluronidase. (Id. ,r 251.)
4. Frost teaches "combinations, compositions and kits containing
a[] fast-acting insulin composition and a hyaluronan degrading enzyme
composition formulated for parenteral administration," such as subcutaneous
administration. (Id. at Abstract, ,r,r 8, 29 (subcutaneous administration).)
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5. Frost teaches that the fast-acting insulin and hyaluronan
degrading enzyme can be administered "separately, intermittently, or
together in separate compositions or co-formulated." (Id. ,r 29.)
6. Frost teaches that "[ t ]he hyaluronan degrading enzyme can be
administered prior, subsequently, intermittently or simultaneously to the
insulin preparation." (Id. ,r 383; see also id. ,r 393 (teaching that "insulin
delivery device can deliver [fast-acting insulin and hyaluronan degrading
enzyme compositions] simultaneously or subsequent to each other").)
7. Frost teaches that, "[g]enerally, the hyaluronan degrading
enzyme is administered prior to or simultaneously with administration of the
insulin preparation to permit the hyaluronan degrading enzyme to degrade
the hyaluronic acid in the interstitial space." (Id.)
8. Frost teaches that, in one example, "the hyaluronan degrading
enzyme composition is administered prior to the insulin composition, such
as 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes or more prior to
administration of the insulin preparation." (Id.)
9. Frost teaches that a skilled artisan would appreciate that "the
desired proximity of co-administration can be readily optimized by testing
the effects of administering the agents at varying times in suitable models,
such as in suitable animal models." (Id.)
10. Frost teaches that
[b ]oth the insulin preparation and the hyaluronan
degrading enzyme preparation can be administered at
once, or can be divided into a number of smaller doses to
be administered at intervals of time. Selected insulin
preparations can be administered in one or more doses
over the course of a treatment time for example over
several minutes, hours, days, weeks, or months. In some
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cases, continuous administration is useful. It is understood
that the precise dosage and course of administration
depends on the indication and patient's tolerability.
(Id. ,r 384.) Frost further teaches that
it is understood that the precise dosage and duration of
treatment is a function of the diabetes being treated and
can be determined empirically using known testing
protocols or by extrapolation from in vivo or in vitro test
data .... Generally, dosage regimens are chosen to limit
toxicity and/or other negative effects, such as excess
insulin.
(Id. ,I 385.)
11. Frost teaches that the composition of its invention can be
administered to a diabetic subject using an insulin delivery device, such as
an insulin pump or other similar continuous infusion device. (Id. ,r 393.)
12. Frost teaches that the fast-acting insulin and hyaluronan
degrading enzyme compositions can be administered continuously or in
bolus injections. (Id.)
Analysis
Claim 1 is directed to a method of controlling blood glucose by CSII
therapy, comprising (a) injecting a bolus of soluble, neutrally active PH20
polypeptide and (b) continuously infusing a composition comprising a fast-
acting insulin by CSII with a continuous infusion device. (Appeal Br. 54
(Claims App.).) Claim 1 further requires that the continuous infusion of
insulin last for more than one day and that the bolus of PH20 in step a) be
administered separately from the insulin and only one time before the
commencement of CSII. (Id.) As discussed above, however, we conclude
that the claim does not preclude administration of additional PH20
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polypeptide after the commencement of CSII and during the course of the
infusion. We further agree with the Examiner that the "whereby" clause
simply expresses an intended result of the positively recited process steps
and thus should not be given patentable weight. 5 Minton v. Nat 'l Ass 'n of
Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003).
Frost teaches a method of controlling blood glucose levels comprising
administration of hyaluronan degrading enzyme and fast-acting insulin.
(FFl .) Frost teaches that the hyaluronan degrading enzyme may be PH20, a
soluble, neutrally active peptide. (FF2, FF3.) Frost teaches that hyaluronan
degrading enzyme and insulin may be administered parenterally, such as via
subcutaneous administration. (FF4.) Frost teaches that the insulin and
5 In the Reply Brief, Appellants contend that the "whereby" clause is not
merely an intended result because, "[t]o achieve the result, only a single
injection ofhyaluronidase followed by CSII therapy for more than a day can
be administered." (Reply Br. 14--15, 18-20.) More specifically, Appellants
contend that "[i]f additional hyaluronidase is administered during the CSII
therapy, then the insulin levels vary over the course of the CSII therapy."
(Id.) We are not persuaded. Appellants cite Example 2 as suggesting that
administering hyaluronidase during CSII would lead to varying insulin
levels. However, Example 2 does not appear to include the step of
administering PH20 prior to commencing continuous CSII (i.e., PH20 is
only administered simultaneously and in formulation with the insulin).
(Spec. 135:23-29.) Thus, Example 2 does not meet all the steps recited in
the claim and does not support Appellants' contention that the "whereby"
clause is more than an intended result of the positively recited process steps.
We also note that, while Appellants contend that the claims recite "methods
in which the levels of insulin are not variable during CSII therapy" (Reply
Br. 18), the whereby clause only recites that "the difference in insulin
absorption is reduced over the course of the insulin infusion compared to
CSII performed in the absence of administering the soluble PH20
polypeptide prior to infusing the fast-acting insulin composition." (Appeal
Br. 54 (Claims App., emphasis added).)
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hyaluronan degrading enzyme may be administered separately and that the
hyaluronan degrading enzyme may be administered prior to the insulin
preparation. (FF5-FF8.) Frost teaches that the hyaluronan degrading
enzyme composition may be administered as a bolus and that the insulin
may be administered continuously via a continuous infusion device over the
course of days. (FF 10, FF 11.) Finally, although Frost does not explicitly
require that hyaluronan degrading enzyme be administered only once before
the commencement of CSII, we find that this limitation is obvious from
Frost's teaching that the enzyme may be administered as a bolus and a short
time (e.g., one minute) prior to administration of insulin. (FF6, FF8, FF12.)
This limitation is further obvious because Frost suggests that the desired
proximity of co-administration of the hyaluronan degrading enzyme and
insulin as well as the precise dosage and course of administration are
routinely optimizable. (FF9, FFlO.)
Accordingly, because claim I involves no more than a predictable
combination of familiar and/or routinely optimizable elements taught in
Frost, we reject this claim pursuant to 35 U.S.C. § 103(a). KS'R Int'! Co. v.
Teleflex Inc., 550 U.S. 398,416 (2007) ("[C]ombination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.").
In responding to the Examiner's anticipation rejection of claim 1,
Appellants contend that "[n]owhere does Frost ... discuss CSII of insulin
for more than a day preceded by a single injection of a ... hyaluronan-
degrading enzyme" and that "[ t Jo read Frost ... as teaching [ the claimed]
regimen requires picking and choosing selected elements out of the
disclosure and combining them as described in this application." (Appeal
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Br. 13, 20----24; see also Reply Br. 14, 16---19 (disputing Examiner's
characterization that claim 1 is a species within the genus of methods
described by Frost).)
As we discussed in reversing the anticipation rejection, while picking,
choosing, and combining disclosures not directly related to each other by
Frost's teachings may be irnproper in an anticipation rejection, such picking
and choosing may be entirely proper in an obviousness analysis. Likewise,
while "[ a ]ny judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning," such reconstruction is
proper "so long as it takes into account only knowledge which was within
the level of ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's disclosure." In re
McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209,212 (CCPA 1971).
Here, the new ground of rejection does not rely on knowledge gleaned only
from Appellants' disclosure. Rather, the new ground combines Frost's
disclosures to arrive at the invention of claim 1, because, as discussed above,
such combination is merely a predictable combination of familiar and/or
routinely optimizable elements taught in Frost. That is, the new obviousness
rejection only takes into account knowledge (Frost) that was within the level
of ordinary skill at the time the claimed invention was made.
Appellants contend that the purpose of the present invention differs
from the purpose of Frost and that Frost does not disclose the problem
solved by the invention. (Appeal Br. 15, 19, 24; see also Reply Br. 18-19.)
In particular, Appellants contend that in the invention "[t]he hyaluronidase is
administered once and before the insulin and is for rnitigating the changes in
insulin levels that occur during a CSII ... set," while Frost "require[ s] co-
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administration of the hyaluronan-degrading enzyme and the insulin
throughout the course of insulin administration to produce super fast-acting
insulin." (Appeal Br. 15; see also id. at 13 (arguing that Frost is concerned
with glucose control during and following a meal), Reply Br. 15 (arguing
that Frost describes administering fast-acting insulin analog and hyaluronan-
degrading enzyme "at substantially the same time before a meal in order
to produce a super fast-acting insulin").)
\Ve are not persuaded. As the Supreme Court has explained, "[i]n
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.
. . . [ A ]ny need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining
the elements in the manner claimed." KSR Int 'l Co. v. Teleflex Inc., 550
U.S. 398, 419-20 (2007). Here, Frost suggests a process that meets all the
steps of the claimed method; thus, it renders the claimed method obvious
even if Frost's process is intended to solve a different problem.
To the extent Appellants' contention is that Frost's invention requires
insulin and hyaluronidase to be administered together and that Frost thus
does not suggest an invention where a single injection of hyaluronidase is
followed by more than a day of CSII without additional administration of
hyaluronidase (see, e.g., Appeal Br. 13, 15----24, Reply Br. 4----20), we have
explained that the broadest reasonable interpretation of claim l does not
preclude additional administration of hyaluronidase during the course of
CSIL
In responding to the obviousness rejection of claim 1, Appellants
make essentially the same arguments as those discussed with respect to the
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anticipation rejection. Specifically, Appellants contend that Frost does not
"teach or suggest any method in which the hyaluronidase is administered as
a single injection (a bolus) one time prior to and separate from CSII of
insulin/or an interval of more than one day." (Appeal Br. 32, 36-38.)
Appellants contend that this claim element "provides the nexus to the results
achieved by the ... claims to minimize differences in insulin absorption that
occur during the course of an infusion set," which are not suggested by Frost
because Frost "requires co-administration of a hyaluronan-degrading
enzyme and a fast-acting insulin analog to produce ... super fast-acting
insulin." (Appeal Br. 32-33, 42; Reply Br. 25-26.) Appellants contend that
"[i]t is the instant application that identifies that the problem[] of glucose
variability that occurs during an infusion set life" and as well as the solution
to the problem, while Frost is directed to solving a different problem.
(Appeal Br. 36-37, 39-42; Reply Br. 25-26.) Appellants further contend
that the Examiner based the rejection on improper hindsight. (Appeal Br.
41; Reply Br. 26-27.)
We are not persuaded for the reasons already discussed above in the
context of the anticipation rejection. With respect to Appellants' argument
that "it long has been recognized that identification of a problem renders the
solution of the problem non-obvious" (Appeal Br. 40), we note that this is
not a situation where a method meeting the limitations of claim 1 was non-
obvious until Appellants' alleged discovery of the problem of glucose
variability over the course of an infusion set. Thus, Appellants have at most
discovered a new property of a method suggested in the prior art, 6 but a
6 We also note that the Specification suggests that the problem of
inconsistent insulin absorption and resulting glucose variability over the
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"newly-discovered property of the prior art cannot support a patent on that
same art." Abbott Labs. v. Baxter Pharm. Products, Inc., 471 F.3d 1363,
1368 (Fed. Cir. 2006).
Appellants also argue, in the context of the obviousness rejection, that
there is no reason to modify Frost's disclosures to arrive at the claimed
invention, and that combining Frost's disclosure to arrive at the claimed
invention would "change the principle of operation of the prior art invention
being modified." (Appeal Br. 37-39, 42.) In particular, Appellants contend
that "[t]here can be no suggestion [in Frost] to administer a one time bolus
of hyaluronidase, followed by a continuous infusion of insulin for more than
one day," because such dosage regimen would not result in Frost's super
fast-acting insulin given that (1) such super fast-acting insulin "requires the
hyaluronan-degrading enzyme and the insulin to be administered together"
and (2) "the effects of increased absorption by administration of a
hyaluronidase typically last less than a day." (Appeal Br. 38-39.) We are
not persuaded because, as already discussed above, claim 1 does not
preclude the administration of additional PH20 over the course of the insulin
infusion, after the initial bolus administration of PH20 prior to the
commencement of CSII - a method of administration suggested by Frost.
Finally, Appellants argue that a comparison of Examples 2 and 3 of
the Specification show that the claimed subject matter exhibits unexpected
results, namely that a single bolus of hyaluronidase administered prior to
infusion of insulin can minimize difference in insulin absorption during the
course of continuous infusion of insulin where the infusion lasts for more
course of an insulin infusion set was known in the prior art. (Spec. 44:11-19
(citing prior art discussing issue).)
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than a day. 7 (See, e.g., Appeal Br. 33; Reply Br. 26.) Appellants contend
that this result is unexpected because "hyaluronidase has a very short half-
life, and nothing in the prior art suggests that a single injection would have
an effect that is observed over the course of more than a day." (Id.)
Appellants contend that the method taught by Frost does not achieve this
unexpected result. (Appeal Br. 33-34.)
We are not persuaded. While we agree that "[ o ]ne way for a patent
applicant to rebut a prima facie case of obviousness is to make a showing of
'unexpected results,' i.e., to show that the claimed invention exhibits some
superior property or advantage that a person of ordinary skill in the relevant
art would have found surprising or unexpected," In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995), "by definition, any superior property must be unexpected to
be considered evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1371 (Fed. Cir. 2007). Furthermore, "it is well settled that
unexpected results must be established by factual evidence. 'Mere argument
or conclusory statements in the specification does not suffice."' In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984)).
Here, the record contains insufficient persuasive evidence that any
difference between the methods of the invention and the prior art with
7 Example 2 in the Specification compares an insulin aspart / human
hyaluronidase formulation (Aspart-PH20) to the commercial insulin aspart
formulation (NovoLog®), which does not contain PH20, for three days of
diabetes treatment delivered by continuous subcutaneous infusion. (Spec.
135:23-26.) Example 3 in the Specification compares patients who received
NovoLog® by CSII over an observation period of approximately 3 days,
either with or without pretreatment with 150 units of human hyaluronidase
(rHuPH20). (Spec. 140:19-11.)
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Application 13/507,261
respect to variability of insulin absorption over the course of an insulin
infusion set is unexpected. While the Federal Circuit has held that "when an
applicant demonstrates substantially improved results ... and states that the
results were unexpected, this should suffice to establish unexpected results in
the absence of evidence to the contrary," In re Soni, 54 F.3d 746, 751 (Fed.
Cir. 1995), in this case the only assertion that the invention exhibits
unexpected results appear in attorney arguments in the brief. Such attorney
arguments, however, cannot take the place of evidence. In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974).
In addition, "[ t ]he evidence presented to rebut a prima facie case of
obviousness must be commensurate in scope with the claims to which it
pertains." In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). In this case, the
evidence Appellants offer pertain only to an embodiment wherein 150 U of
PH20 was administered within a few minutes prior to CSII over an
observation period of approximately 3 days (Spec. 141:4--10), even though
the claims encompass broader ranges with respect to, among other things,
the number of units of PH20 administered, when PH20 is administered prior
to commencement of CSII, and the length of the infusion set. (See, e.g.,
Appeal Br. 54--55 (Claims App., claims 2 and 21 (PH20 administered in an
amount that is at least 1 Unit, functionally equivalent to between 1 Unit to
200 Units, or between 8 ng to 2 µg); claims 13 and 14 (PH20 administered 1
minute to 12 hours or no more than 2 hours before insulin infusion); claims
1, 8, and 9 (insulin infusion of more than 1 day or 2 days to 4 days)).)
Accordingly, we are not persuaded by Appellants' arguments on the
current record regarding the non-obviousness of claim 1 over Frost.
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Application 13/507,261
SUMMARY
We reverse the Examiner's rejection of claims 1-5, 9-11, 13-14, 16,
19-21, 25-29, 32, and 33 as anticipated by Frost.
We reverse the Examiner's rejection of claims 1-14, 16, 19-21, 2 5-
29, 32, and 33 as obvious over Frost.
We enter a new ground of rejection of claim 1 as obvious over Frost.
We have not entered new rejections of the dependent claims, but in the event
of further prosecution (see below), the Examiner should consider whether
any of the dependent claims should also be rejected over the prior art.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision,
must exercise one of the following two options with
respect to the new ground of rejection to avoid termination
of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence
relating to the claims so rejected, or both, and have the
matter reconsidered by the examiner, in which event the
prosecution will be remanded to the examiner. The new
ground of rejection is binding upon the examiner unless an
amendment or new Evidence not previously of Record is
made which, in the opinion of the examiner, overcomes
the new ground of rejection designated in the decision.
Should the examiner reject the claims, appellant may again
appeal to the Board pursuant to this subpart.
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Appeal2017-002692
Application 13/507,261
(2) Request rehearing. Request that the proceeding
be reheard under § 41.52 by the Board upon the same
Record. The request for rehearing must address any new
ground of rejection and state with particularity the points
believed to have been misapprehended or overlooked in
entering the new ground of rejection and also state all
other grounds upon which rehearing is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED; 37 C.F.R. § 4I.50(B)
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